Artificial urinary sphincter system

ABSTRACT

An artificial urinary sphincter (AUS) system includes a cuff, a pump, and a single tube that provides the system with an inflatable storage compartment. The single tube is connected between the cuff and the pump and includes a first lumen communicating between the cuff and the pump and a separate second lumen communicating between the cuff and the pump. The cuff is inflatable with a cuff volume of liquid that is sized to selectively close the urethra for treatment of urinary incontinence. The pump is operable to move the cuff volume of liquid out of the cuff to provide the cuff with a deflated state that allows the urethra to open and pass urine. The second lumen has a storage compartment sized to retain the cuff volume of liquid.

BACKGROUND

Urinary incontinence affects about 200 million people worldwide andabout 25 million people in the US. Urinary incontinence is generallymore prevalent in women than in men.

Urinary incontinence in women can be associated with a prolapse of oneor more pelvic organs, which can arise from a weakness in thetissues/muscle of the pelvic floor. Urinary incontinence in men canarise after surgical treatment of the prostate glade, which treatmentcan include removal or weakening of the prostatic sphincter associatedwith the urinary urethra.

One treatment for urinary incontinence includes placing an artificialsphincter around a portion of the urethra. The artificial sphincter hasa closed position that selectively prevents the flow of urine throughthe urethra, thus providing the user with a comfortable, continentstate. The artificial sphincter can be activated to an open position bythe user, which opens the urethra and allows the user to selectivelypass urine.

Surgeons and patients would welcome advances in the treatment of urinaryincontinence.

SUMMARY

One aspect provides an artificial urinary sphincter (AUS) systemincluding a cuff, a pump, and a single tube that provides the systemwith a storage compartment. The system is a closed system having liquidin the cuff that inflates the cuff to coapt the urethra. The pump isoperable to move the liquid out of the cuff to provide the cuff with adeflated state that allows the urethra to open and pass urine. Thesingle tube stores the energy of the closed system and is operable tostore the liquid moved out of the cuff. In this manner, the single tubereplaces the role of and does away with the extra component of apressurized balloon reservoir.

One aspect provides an artificial urinary sphincter (AUS) systemincluding a cuff, a pump, and a tube that provides the system with aninflatable storage compartment. The cuff is sized to be placed around aurethra of a user and is configured to coapt the urethra in treatingurinary incontinence. The pump is configured to move liquid out of thecuff to provide the cuff with a collapsed state that allows the urethrato pass urine. The tube is connected between the cuff and the pump andincludes a first lumen separated from a second lumen by a wall internalto the tube. The second lumen includes an exposed exterior wall and atleast a portion of the exposed exterior wall of the second lumen isconfigured to expand to provide the second lumen with the inflatablestorage compartment.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily drawn to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of an artificial urinarysphincter (AUS) system implanted in the urogenital region of a malepatient.

FIG. 2 is a side view and FIG. 3 is a top view of one embodiment of acuff of the AUS system illustrated in FIG. 1.

FIG. 4 is an end view of the cuff illustrated in FIG. 2 as assembled andshowing a deflated and an inflated configuration.

FIG. 5 is a perspective view of one embodiment of a pump of the AUSsystem illustrated in FIG. 1.

FIG. 6 is a cross-sectional view of one embodiment of the pumpillustrated in FIG. 5.

FIG. 7 is a cross-sectional view of one embodiment of a tube of the AUSsystem illustrated in FIG. 1.

FIG. 8 is a cross-sectional view of one embodiment of the tubeillustrated in FIG. 7 providing an inflatable storage compartment.

FIG. 9 is an end view and FIG. 10 is a cross-sectional view of oneembodiment of an end of the tube that is connected to the cuff of theAUS system illustrated in FIG. 1.

FIG. 11A is a cross-sectional view of the AUS system illustrated in FIG.1 in a rest or equilibrium state configured to coapt a urethra of auser.

FIG. 11B is a cross-sectional view of the AUS system illustrated in FIG.1 in an activated state configured to allow the urethra of the user toopen and pass urine.

FIG. 12A is a longitudinal cross-sectional view and FIG. 12B is alateral cross-sectional view of one embodiment of an artificial urinarysphincter (AUS) system.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

As employed in this specification, the term “end” means endmost or thevery end point of the subject being described, and the term “endportion” means that segment that is immediately adjacent to the end ofthe subject being described.

One urinary control system that has found favor with the medicalcommunity includes three components cooperatively attached withkink-resistant tubing: an occlusive cuff, a control pump, and apressure-regulating balloon reservoir. The cuff is implanted around theurethra. The control pump is implanted in the scrotum of a male user.The pressure-regulating balloon reservoir is implanted in the prevesicalspace, for example through a suprapubic incision followed by dissectionof the rectus fascia and a spreading of the linea alba. The threecomponents are filled with liquid (saline) to provide a liquid-filledclosed system maintained at an equilibrium pressure that closes the cuffaround the urethra. When the user wishes to void, he squeezes andreleases the pump several times to move fluid from the cuff into thepressure-regulating balloon reservoir. The cuff “deflates” and opens,which allows the urethra to open and pass urine. The pressure-regulatingballoon reservoir, having been pressurized to a pressure above theequilibrium pressure by action of the pump, eventually automaticallyre-pressurizes the cuff to the equilibrium pressure over the course ofseveral minutes to again inflate the cuff and coapt the urethra.

Embodiments described in this application provide a system that isprovided with a conduit extending between a cuff and a pump of thesystem, where the conduit includes an inflatable storage compartmentthat expands to retain/store the volume of liquid maintained in theclosed system. The system can be adapted to provide treatment forurinary incontinence in which the conduit extends between a pump and anartificial urinary sphincter of the system. Separately, the system canbe adapted to provide treatment for erectile dysfunction in which theconduit extends between a pump and an inflatable penile cylinder of thesystem. In any regard, the system described in this patent applicationis characterized by the absence of a pressure-regulating balloonreservoir that ordinarily stores the liquid and pressurizes the closedsystem. In one embodiment, the system described by the embodiments hastwo components cooperatively attached with the conduit, namely a cuffand a pump.

The exemplary AUS system described in this patent application is suitedfor use both in female patients and in male patients, where the cuff isplaced around a portion of the urethra. Female patients will have thepump component implanted in one of the labia or in an abdominal area.Male patients will have the pump component implanted in the scrotum.

One advantage of the two-component AUS system described in this patentapplication is that the pressure-regulating balloon reservoir is doneaway with and its function is provided by the newly described conduitconnected between the cuff and the pump. Thus, fewer components areimplanted into the user, which provides a smaller AUS device that iseasier to implant and offers a quicker recovery time from theimplantation surgery.

FIG. 1 is a perspective view of one embodiment of an artificial urinarysphincter (AUS) system 20 illustrated as implanted in the environment ofthe male urogenital region. Although the illustrated environment is thatof a male user, the system is also suited for implantation into a femaleuser.

The AUS system 20 includes a cuff 22 that is sized to be placed around aurethra U, a pump 24 that is sized for placement within the scrotum S,and a tube 26 or conduit 26 that is attached between the cuff 22 and thepump 24. The AUS system 20 is characterized by the absence of a separatereservoir that is ordinarily provided to retain the liquid that istransferred to inflate the cuff 22. Embodiments of the AUS system 20configure the tube 26 or the conduit 26 to provide an expandable andinflatable storage compartment that stores liquid transferred out of thecuff 22 when the cuff 22 is deflated.

The AUS system 20 can be referred to as a two component system, wherethe two components include the cuff 22 and the pump 24. In contrast, atypical three component system would include a cuff attached to aseparate reservoir and a pump attached to the cuff.

The cuff 22 is implanted around the bulbous urethra or around theportion of the urethra descending from the bladder neck N. The cuff 22is sized to allow placement as close to the bladder B as possible(desired by some surgeons), or positioned distal the bladder neck N assuitably determined by the surgeon. As illustrated in FIG. 1, the cuff22 is implanted around the urethra U at a location where the urethra Utransitions from a vertical orientation communicating with the bladder Bto a horizontal orientation extending to the penis P, which correspondsto the area of the urogenital region associated with an increased levelof muscle M mass. The cuff 22 is generally about 2 cm wide and havevarying lengths suited to different anatomical sizes, where the lengthsare provided in a range between 4-11 cm.

The pump 24 is typically implanted within the scrotum S, which providesaccess to the pump 24 by the user. Other locations for placement of thepump 24 are also acceptable.

The tube 26 is connected between the cuff 22 and the pump 24, and whenimplanted thus extends from a location in the scrotum S to a locationdistal the bladder B.

FIG. 2 is a side view and FIG. 3 is a top view of one embodiment of thecuff 22. The cuff 22 includes an expanding bladder portion 32 attachedto a base 30. A connector 34 is provided on the base 30 for connectionwith the tube 26 (FIG. 1), and the connector 34 communicates with thebladder portion 32. In one embodiment, the expanding bladder portion 32is provided as a series of segments or pillows 32 a, 32 b, 32 c that areconfigured to expand and inflate as liquid is directed into the cuff 22through the connector 34. In one embodiment, three of the segments orpillows are provided to allow the base 30 to be bent/folded or directedaround the circumference of the urethra such that when the pillows 32expand, substantially uniform pressure is applied to the urethra. Thebladder portion 32 may include more than three or fewer than twosegments or pillows.

In one embodiment, the base 30 extends from a first end portion 36provided with a tab 38 to a second opposing end portion 40 provided witha slot 42. Inserting the tab 38 into the slot 42 forms the cuff 22 intoa substantially circular configuration configured for encircling theurethra of the user. Movement of liquid through the connector 34 (forexample by the pump 24 shown in FIG. 1) expands or inflates the bladderportion 32, which is useful in inflating the cuff 22 to coapt theurethra to provide the user with a continent state.

FIG. 4 is an end view of the cuff 22 with the tab 38 inserted into theslot 42 to form the cuff 22 into a substantially circular shape. Thecuff 22 may thus be manipulated for placement around the urethra. Whenthe cuff 22 is deflated (as illustrated by the dotted lines), thebladder portion 32 is retracted to remove or diminish pressure appliedto the urethra, which allows the urethra to open and pass urine. Incontrast, when the cuff 22 is inflated (as illustrated by the solidlines), the bladder portion 32 expands to apply pressure against theurethra to coapt the urethra and provide the user with a comfortable,continent state.

The cuff 22 is generally fabricated from synthetic material that issuitable for implantation into the human body and configured to retain avolume of liquid (for example when the bladder portion 32 of the cuff 22is inflated). Suitable materials for fabricating the cuff 22 includesilicone, flexible block copolymers, polyolefin, polybutylene,polyurethane, or mixtures or suitable copolymers of the syntheticmaterials.

FIG. 5 is a perspective view of the pump 24. The pump 24 includes a bulb50 connected to a housing 52 that encloses one or more valve assemblies54 (see FIG. 6). In one embodiment, the valve assemblies 54 are providedas a component of the pump 24. In an alternate and acceptableembodiment, the valve assemblies 54 are integrated with and provided asa component of the tube 26.

FIG. 6 is a cross-sectional view of the pump bulb 50 and the housing 52.In one embodiment, the valve assemblies 54 include an intake valveassembly 56 and an exhaust valve assembly 58. The intake valve assembly56 is configured to allow liquid to move out of the cuff 22 (FIG. 1) andinto the bulb 50. The exhaust valve assembly 58 is configured to openwhen the bulb 50 is squeezed or pressurized, which drives the liquid outof the bulb 50 and into a storage compartment 60 that is provided withinthe tube 26.

In one embodiment, the intake valve assembly 56 includes a ball 70 thatis biased against a valve seat 72 by a spring 74. Compressing andreleasing the bulb 50 will create a local low pressure (suction) thatwill draw liquid from the cuff 22 across the valve seat 72, around theball 70, and into the bulb 50. Subsequent repeated pressing of the bulb50 will drive the liquid from the bulb 50 through the exhaust valveassembly 58.

In one embodiment, the exhaust valve assembly 58 includes a ball 80 thatis biased against a valve seat 82 by a spring 84. Pressure created inthe bulb 50 will cause the liquid ejected from the bulb 50 to force theball 80 off of the valve seat 82 and drive the liquid into the storagecompartment 60.

In one embodiment, the intake valve assembly 56 and the exhaust valveassembly 58 are each suitably provided as a one-way valve assembly. Inone embodiment, the tube 26 includes a first one-way valve assembly 56that is configured to allow liquid to flow from the cuff 22 to the pump24, and a second one-way valve assembly 58 that is configured to allowthe liquid to flow from the pump 24 and into the storage compartment 60.A bleeder valve (FIGS. 9 and 10) is configured to allow the liquid tosubsequently and gradually flow from the second lumen 92 back into thecuff 22. Other suitable valve assemblies that allow liquid toselectively flow from the cuff 22, into the bulb 50, and into thestorage compartment 60 are also acceptable.

In one embodiment, the tube 26 is attachable to the pump 24, for exampleafter the pump 24 and the cuff 22 (FIG. 1) are implanted.

In one embodiment, the tube 26 and the pump 24 are integrated as amonolithic one-piece assembly.

The pump 24 is suitably fabricated from synthetic materials such asthose materials identified above for the cuff 22. One suitable materialfor fabricating the pump 24 is silicone.

FIG. 7 is a cross-sectional view of one embodiment of the tube 26. Thetube 26 communicates with the pump 24 via the housing 52 that enclosesthe valve assemblies 54. In one embodiment, the valve assemblies 54 areintegrated into the tube 26 and the tube is integrated seamlessly withthe pump 24.

In one embodiment, the tube 26 includes a first lumen 90 separated froma second lumen 92 by a wall 94 that is internal to the tube 26. In oneembodiment, the second lumen 92 includes an exposed exterior wall 96,and at least a portion 98 of the exposed exterior wall 96 is configuredto expand to provide the second lumen 92 with an inflatable storagecompartment 60. As one example, less than half of the circumference ofthe tube 26 (less than 180 degrees of the circumference of the tube 26,or approximately 90 degrees of the circumference of the exterior wall 96of the entire tube 26) is fabricated in a manner that allows the portion98 to expand when pressurized. This expansion feature may be achieved byproviding the portion 98 of the exterior wall 96 with a thinner wallsection as compared to the remainder of the exterior wall 96, as oneexample.

In one embodiment, the tube 26 is a single tube that is integrated toinclude the first lumen 90 communicating between the cuff 22 and thepump 24 and the separate second lumen 92 communicating between the cuff22 and the pump 24. In one embodiment, the lumens 90, 92 are integratedas a monolithic one-piece assembly.

Alternatively, the expansion feature may be achieved by providing theportion 98 of the exterior wall 96 with a more flexible material (lowerdurometer) section as compared to the remainder of the exterior wall 96.The durometer or hardness/expandability of the portion 98 of theexterior wall 96 of the tube 26 may be selectively adjusted to achievean appropriate amount of expansion, for example by adjusting thedurometer or hardness of the portion 98 to be lower than thedurometer/hardness of the remaining part of the tube 26. As one example,the portion 98 of the exposed exterior wall 96 of the second lumen 92 isfabricated from a material having a lower hardness durometer than ahardness durometer of a remaining portion of the tube 26. One suitableexample provides the portion 98 of the exposed exterior wall 96 of thesecond lumen 92 with a durometer in a range from 10-40 Shore A hardnessand the remaining portion of the tube 26 is provided with a durometer ina range from 45-90 Shore A hardness. This configures the portion 98 toexpand more than the rest of the tube 26 when the lumen 92 ispressurized about the equilibrium pressure.

In one embodiment, the tube 26 is a substantially cylindrical tube andthe wall 94 internal to the tube 26 is centrally located on alongitudinal diameter of the tube 26.

In one embodiment, the exterior wall 96 is provided with a firstthickness T1 and the expandable portion 98 of the exposed exterior wall96 is provided with a second thickness T2. In one embodiment, the firstthickness T1 is greater than the second thickness T2, which configuresthe tube 26 to have a region (i.e., portion 98) that will expand/bulgein response to an increase in force, for example when the second lumen92 is pressurized. One suitable range for the first thickness T 1 of theexterior wall 96 is between about 0.035-0.100 inches. One suitable rangefor the second thickness T2 of the expandable portion 98 is betweenabout 0.005-0.025 inches.

FIG. 7 illustrates one embodiment of the tube 26 section of theassembled AUS system 20 provided as a closed system and maintained at anequilibrium pressure Pe. The equilibrium pressure Pe is selected toprovide a sufficient pressure to expand the cuff 22 (FIG. 1) and coaptthe urethra when the AUS system 20 is in the rest state, which ensuresthat the user is maintained in a comfortable and continent state untils/he desires to void urine. A suitable range for equilibrium pressuresPe of the closed AUS system 20 is between about 30-80 cm of water. Onesuitable equilibrium pressure Pe for the AUS system 20 is about 60 cm ofwater.

FIG. 8 illustrates one embodiment of the storage compartment 60 of theAUS system 20 maintained at a storage pressure Ps. The exposed exteriorwall 96 of the second lumen 92 is configured to expand at a storagepressure Ps that is greater than the equilibrium pressure Pe, whichexpands the portion 98 of the wall 96 and maintains the storagecompartment 60 at the storage pressure Ps. Storing the liquid from thecuff 22 in the storage compartment 60 will deflate the cuff 22, whichremoves pressure from the urethra and allows the user to pass urine. Asuitable range for storage pressures Ps of the AUS system 20 is betweenabout 85-120 cm of water. One suitable storage pressure Ps for the AUSsystem 20 is about 90 cm of water.

In one embodiment, the storage compartment 60 is sized and configured tostore substantially all of the liquid volume maintained in the cuff 22(FIG. 1). For example, when the cuff 22 is deflated by a volume V todeflate the cuff 22 and allow the user to pass urine, the storagecompartment 60 expands to accept the additional volume V. Thus, thestorage compartment 60 provides a storage reservoir to hold theadditional volume V. The second lumen 92 is configured to expand toprovide the system 20 with a pressure-regulating storage compartment.

FIG. 9 is an end view and FIG. 10 is a cross-sectional view of one endof the tube 26 that communicates with the cuff 22 (FIG. 4). As describedabove, a portion of the tube 26 is configured to provide a reservoirfunction and store a volume of liquid that is drained from the cuff 22,which allows the cuff 22 to relax or deflate, thus removing pressureapplied to the urethra and allowing the user to pass urine. After theuser has passed urine, it is desirable to coapt the urethra and returnthe user to a continent state. In one embodiment, the end of the tube 26that communicates with the cuff 22 is provided with a bleeder valve 100that communicates with the cuff 22. The bleeder valve 100 is configuredto allow the liquid that is stored in the storage compartment 60 of thesecond lumen 92 to eventually transfer back into the cuff 22. In otherwords, the bleeder valve 100 is configured to dissipate the liquidstored in the storage compartment 60 of the second lumen 92 from thehigher storage pressure Ps to the lower equilibrium pressure Pe, thusreturning the system 20 to the equilibrium pressure Pe.

In one embodiment, the bleeder valve 100 is provided as a diaphragmhaving a small orifice 102 that is sized to allow liquid to slowly passthrough the bleeder valve 100 and into the cuff 22 to equalize thepressure of the system 20 to the equilibrium pressure Pe. The bleedervalve 100 is illustrated as a diaphragm having a single orifice 102,although other forms for the bleeder valve are also acceptable. Forexample, an array of orifices could be provided in a diaphragm of thebleeder valve 100 that would allow the liquid in the storage compartment60 to flow in a controlled and time-lapsed manner back into the cuff 22and return the system 22 to its equilibrium pressure Pe.

FIG. 11A is a cross-sectional view of the AUS system 20 in a rest orequilibrium state operating to coapt a urethra U of a user. Theillustrated view of FIG. 11A is not to scale. The system 20 is initiallyfilled with a fill volume of liquid of about 40 cc and the components(cuff 22, pump 24, and tube 26) are sealed in a closed system to retainthe fill volume of liquid. The closed system 20 is maintained at theequilibrium pressure Pe. Specifically, each pillow 32 a, 32 b, 32 c ofthe expanding bladder 32 of the cuff 22 is maintained at the equilibriumpressure Pe, which is selected to provide a calculated and sufficientamount of pressure against the urethra U in order to close the urethraand provide the user with a continent state. The first lumen 90, thebulb 50, and the second lumen 92 are also maintained at the equilibriumpressure Pe. The second lumen 92 is sized to retain a first volume V1 ofliquid when the system 20 is at equilibrium.

FIG. 11B is a cross-sectional view of the AUS system 20 in an activatedstate configured to allow the urethra U of the user to open and passurine. The illustrated view of FIG. 11B is not to scale. The system 20has been activated to move away from the equilibrium state, for exampleby pumping the bulb 50 of the pump 24 to move liquid out of the cuff 22and into the storage compartment 60. In the activated state, the pillows32 a, 32 b, 32 c of the cuff 22 have been deflated by moving liquid outof the cuff 22, through the pump 24, and into the storage compartment60. The urethra U opens to allow the urethra U to pass urine. The pump24 pressurizes the liquid in the second lumen 92/storage compartment 60to the storage pressure Ps. The portion 98 of the second lumen 92expands and stores the liquid that was removed from the cuff 22. Thestorage pressure Ps is greater than the equilibrium pressure Pe. Theportion 98 of the exterior wall 96 of the second lumen 92 is configuredto expand when exposed to the storage pressure Ps. The evacuation of theliquid out of the cuff 22 and into the storage compartment 60 results ina pressure P1 of the first lumen 90 that is lower than the equilibriumpressure Pe and the storage pressure Ps.

In one embodiment, the storage compartment 60 of the second lumen 92 hasa storage volume V2 that is greater than the first volume V1 of theat-rest/equilibrium state of the second lumen 92. In one embodiment, thefirst lumen 90 and the second lumen 92 each have approximately equalvolumes when the system 20 is maintained at the equilibrium pressure Pe.In one embodiment, the second lumen 92 has a first volume V1 at theequilibrium pressure Pe and the second lumen 92 has a second volume V2at the storage pressure Ps that is approximately twice the first volumeV1. In one embodiment, the second lumen 92 has a first volume V1 at theequilibrium pressure Pe and the second lumen 92 has a second volume V2at the storage pressure Ps that is more than twice the first volume V1.For example, the second lumen 92 has a second volume V2 at the storagepressure Ps that is three times, or four times, or 3-6 times the firstvolume V1

With reference to both FIG. 11A and FIG. 11B, the cuff 22 is configuredto coapt the urethra U when the system 20 is at the equilibrium pressurePe, and the exposed exterior wall 96 of the second lumen 92 isconfigured to expand at the storage pressure Ps (Ps is greater than Pe)to store the liquid that has been removed from the cuff 22. The movementof the liquid out of the cuff 22 and into the storage compartment 60lowers the pressure and the cuff 22, which allows the urethra U to openand pass urine.

With reference to FIG. 11B, the liquid volume V2 maintained in thestorage compartment 60 will eventually pass through the bleeder valve100 and flow back into the cuff 22. The bleeder valve 100 is configuredto allow the system 20 to return to the equilibrium pressure Pe over aperiod of time of several minutes, but less than about one hour, whichreturns the user to the continent state.

FIG. 11A illustrates the cuff 22 inflated at the equilibrium pressure Pewith a cuff volume of liquid that functions to selectively close theurethra U for treatment of urinary incontinence.

FIG. 11B illustrates the pump operated to move the cuff volume of liquidout of the cuff 22 to provide the cuff 22 with a deflated state thatallows the urethra U to open and pass urine. The storage compartment 60of the second lumen 92 retains the cuff volume of liquid. The singletube 26 is configured to store the energy of the closed system,including the energy maintained at the equilibrium pressure Pe and theenergy when the storage compartment 60 is pressurized to the storagepressure Ps.

The system 20 is designed to provide a closed system with an equilibriumpressure Pe selected to provide a sufficient pressure to coapt theurethra when the AUS system 20 is in the rest state, which ensures thatthe user is maintained in a comfortable and continent state until s/hedesires to void urine. A suitable range for equilibrium pressures Pe ofthe closed AUS system 20 is between about 30-80 cm of water. Onesuitable equilibrium pressure Pe for the AUS system 20 is about 60 cm ofwater. The storage compartment 60 is configured to expand at a storagepressure Ps that is greater than the equilibrium pressure Pe as the cuff22 is deflated. A suitable range for storage pressures Ps of the AUSsystem 20 is between about 85-120 cm of water. One suitable storagepressure Ps for the AUS system 20 is about 90 cm of water.

The system 20 includes the conduit 26 that is a pressure-regulatingliquid storage reservoir 26. At least a portion of thepressure-regulating liquid storage reservoir 26 is pressurizeable to apressure above the steady-state equilibrium pressure of the system. Thepressure-regulating liquid storage reservoir 26 includes the storagecompartment 60 that inflates to hold the volume of liquid moved from thecuff 22, and after holding the increased pressure allows the system 20to regulate back to the equilibrium pressure by allowing liquid to flowthrough the bleeder valve 100.

In contrast to other AUS systems that have a cuff and apressure-regulating balloon, the system 20 includes a conduit 26 thatplays the role of a pressure-regulating balloon by holding the volume ofliquid that acted to coapt the urethra (the liquid in the cuff 22).

FIG. 12A is a cross-sectional view of one embodiment of an AUS system100 including a tube 126 that provides the system 100 with apressure-regulating liquid storage reservoir. The tube 126 communicateswith the pump 24 described above via the housing 52 that encloses thevalve assemblies 54. The tube 126 is attached to the cuff 22 describedabove. In one embodiment, the tube 126 includes a first lumen 190 thatis provided to remove liquid from the cuff 22 and a second lumen 192that circumferentially surrounds the first lumen 190. The first lumen190 is separated from the second lumen 92 by a wall 194 that is internalto the tube 126.

FIG. 12B is a cross-sectional view of the tube 126 taken through acentral portion of the second lumen 192. In one embodiment, the secondlumen 192 includes an exposed circumferential exterior wall 196, and atleast a portion 198 of the exposed exterior wall 196 is configured toexpand to provide the second lumen 192 with an inflatable andpressure-regulating liquid storage compartment 160. In this embodiment,an outer circumferential compartment 160 surrounds 360 degrees of thetube 126. That is, the second lumen 192 circumferentially surrounds thefirst lumen 190.

In one embodiment, the system 20 is provided as a kit of parts to asurgeon or clinic/hospital facility for the treatment of urinaryincontinence. The kit of parts is provided with documentation orinstructions for use describing and reviewing the surgical procedure bywhich the surgeon has been trained for implantation of the system 20.

The kit of parts is provided in a package to treat urinary incontinenceand includes the cuff 22 that is sized for placement around the urethraU, a pump 24 that is sized to move liquid out of the cuff 22, and a tube26 that is attachable between the cuff 22 and the pump 24. The tube 26is fabricated to include a first lumen 90 and a second lumen 92 thatboth communicate between the cuff 22 and the pump 24, as describedabove. At least a portion 98 of the exposed exterior wall 96 of thesecond lumen 92 is fabricated to expand to provide the second lumen 92with an inflatable storage compartment 60. The inflatable storagecompartment 60 is sized to receive and store the volume of liquid thatis transferred out of the cuff 22 when the cuff 22 is deflated (i.e.,when the user passes urine).

A method of treating a patient suffering from urinary incontinence withthe system 20 includes a surgical procedure to implant the system 20.The patient is prepared for surgery in a manner described by thehospital or clinic policies or as supervised and approved by thesurgeon. The perineal area of the patient is cleaned with suitablecleansers and prepared for surgery. A perineal incision is made on themidline of the patient, and tissue is dissected to expose thebulbospongiosus muscle supporting the urethra U. The surgeon willdissect laterally to free the fascia around the bulbospongiosus muscleand expose a portion of the bulbar urethra U. The bulbospongiosus muscleis immobilized, for example by clamping laterally to each side of thepatient, which exposes the urethra for access by the surgeon. Thesurgeon dissects additional tissue and muscle by “tunneling” around theposterior side of the urethra to create a pathway around a circumferenceof the urethra. The cuff 22 is traversed along the pathway around theurethra U until a portion of the cuff 22 is posterior to the urethra Uwith the tab 36 and a slot 42 of the cuff 22 anterior to the urethra U.The tab 36 is inserted into the slot 42 to secure the cuff 22 around theurethra U.

The surgeon typically confirms performance of the cuff 22 by injectingliquid into the connector 34 or the system 20, usually immediately priorto implantation of the system 20. The tube 26 and the pump 24 aresubsequently attached to the cuff 22. For example, the pump 24 islocated in the scrotum (male) or labia (female) of the user and the tube26 is connected between the pump 24 and the cuff 22 that has been placedaround the urethra U. The surgeon will pressurize the system 20 to theequilibrium pressure Pe and cause the cuff 22 to coapt the urethra U.The surgeon will confirm that operation of the pump 24 will removeliquid from the cuff 22, thus opening the urethra U and allowing thepatient to pass urine. The surgical site is closed after confirmation ofperformance of the system 20.

Embodiments of treating urinary incontinence include fabricating thetube 26, 126 to include a first lumen separated from a second lumen by awall internal to the tube; and fabricating at least a portion of anexposed exterior wall of the second lumen to expand to provide thesecond lumen with an inflatable storage compartment; and providing to asurgeon instructions for use on implantation of the device.

Embodiments of treating urinary incontinence include connecting a firstend of the pressure-regulating storage compartment tube 26, 126 to thecuff 22 and connecting a second end of the pressure-regulating storagecompartment tube 26, 126 to the pump 24.

Embodiments provide a “fail-safe” system 20 that is implanted into thepatient and maintained at the equilibrium pressure Pe. In the event thatthe system 20 develops an undesirable leak, the system 20 willde-pressurize to a pressure of less than the equilibrium pressure Pe,which will result in the cuff 22 deflating to allow the urethra to open.Thus, in the event that the system 20 experiences a non-steady stateevent, the cuff 22 opens to allow the user to pass urine.

Embodiments of the artificial urinary sphincter (AUS) system describedabove include a fully functional system for treating urinaryincontinence that operates in the absence of a reservoir providedseparate from the tubing, cuff, and pump. The tube or tubing isconnected between the cuff and the pump and includes a lumen that isconfigured to expand to provide the lumen/system with an inflatablestorage compartment.

Although specific embodiments have been illustrated and described inthis patent application, it will be appreciated by those of ordinaryskill in the art that a variety of alternate and/or equivalentimplementations may be substituted for the specific embodiments shownand described without departing from the scope of the invention. Thispatent application is intended to cover any adaptations or variations ofmedical devices, as discussed above. Therefore, it is intended that thisinvention be limited only by the claims and their equivalents.

What is claimed is:
 1. An artificial urinary sphincter systemcomprising: a cuff implantable around a urethra of a user; a pumpcommunicating with the cuff; and a single tube connected between thecuff and the pump, the single tube integrated to comprise a first lumencommunicating between the cuff and the pump and a separate second lumencommunicating between the cuff and the pump; wherein the cuff isinflatable with a cuff volume of liquid that is sized to selectivelyclose the urethra for treatment of urinary incontinence, and the pump isoperable to move the cuff volume of liquid out of the cuff to providethe cuff with a deflated state that allows the urethra to open and passurine, and the second lumen has a storage compartment sized to retainthe cuff volume of liquid.
 2. The system of claim 1, wherein the secondlumen is expandable to provide the single tube with an expandablestorage compartment sized to retain the cuff volume of liquid.
 3. Thesystem of claim 1, wherein the first lumen is longitudinally alignedside-by-side with the second lumen, the first lumen separated from thesecond lumen by a wall internal to the single tube.
 4. The system ofclaim 1, wherein the second lumen circumferentially surrounds the firstlumen.
 5. An artificial urinary sphincter system comprising: a cuffplaceable around a urethra of a user and configured to selectively closethe urethra for treatment of urinary incontinence; a pump configured tomove liquid out of the cuff to provide the cuff with a deflated statethat allows the urethra to open and pass urine; and a tube connectedbetween the cuff and the pump, the tube comprising a first lumenseparated from a second lumen; wherein the second lumen provides thesystem with a pressure-regulating storage compartment.
 6. The system ofclaim 5, wherein the tube is a substantially cylindrical tube and thefirst lumen is separated from the second lumen by a wall that isinternal to the tube and centrally located on a diameter of the tube. 7.The system of claim 5, wherein the system has a first pressure in thesecond lumen that coapts the urethra and the system has a secondpressure in the second lumen that is greater than the first pressurethat operates to expand the second lumen.
 8. The system of claim 5,wherein the system has an equilibrium pressure at which the cuff isconfigured to coapt the urethra and the second lumen is configured toexpand at a storage pressure that is greater than the equilibriumpressure to provide the second lumen with the pressure-regulatingstorage compartment.
 9. The system of claim 8, wherein the second lumenhas a first volume at the equilibrium pressure and the second lumen hasa second volume at the storage pressure that is approximately twice thefirst volume.
 10. The system of claim 8, wherein the second lumen has afirst volume at the equilibrium pressure and the second lumen has asecond volume at the storage pressure that is not less than twice thefirst volume.
 11. The system of claim 8, wherein the first lumen and thesecond lumen each have approximately equal volumes at the equilibriumpressure.
 12. The system of claim 8, wherein the system furthercomprises a bleeder valve in communication with the cuff, the bleedervalve configured to return the second lumen from the storage pressure tothe equilibrium pressure.
 13. The system of claim 5, wherein the firstlumen includes a first one-way valve that is configured to allow liquidto flow from the cuff to the pump, and the second lumen includes asecond one-way valve that is configured to allow the liquid to flow fromthe pump to the second lumen.
 14. The system of claim 13, wherein andthe second lumen further comprises a bleeder valve in communication withthe cuff, the bleeder valve configured to allow the liquid to flow fromthe second lumen into the cuff.
 15. An artificial urinary sphinctersystem comprising: a cuff placeable around a urethra of a user andconfigured to coapt the urethra in treating urinary incontinence; a pumpconfigured to move liquid out of the cuff to provide the cuff withcollapsed state that allows the urethra to pass urine; and a tubeconnected between the cuff and the pump, the tube comprising a firstlumen separated from a second lumen by a wall internal to the tube, andat least a portion of an exposed exterior wall of the second lumen isconfigured to expand to provide the second lumen with an inflatablestorage compartment; wherein the first lumen includes a first one-wayvalve that is configured to allow liquid to flow from the cuff to thepump, and the second lumen includes a second one-way valve that isconfigured to allow the liquid to flow from the pump to the second lumenand a bleeder valve in communication with the cuff, the bleeder valveconfigured to allow the liquid to flow from the second lumen into thecuff.
 16. The system of claim 15, wherein the tube and the pump areintegrated as a monolithic one-piece assembly.
 17. The system of claim15, wherein an exterior wall of the tube of the second lumen has a firstthickness and the portion of the exposed exterior wall of the secondlumen has a second thickness that is less than the first thickness. 18.The system of claim 15, wherein the exposed exterior wall of the secondlumen has a lower hardness durometer than a hardness durometer of aremaining portion of the tube.
 19. The system of claim 15, wherein thebleeder valve includes a diaphragm formed to include at least oneorifice.
 20. A method of treating urinary incontinence, the methodcomprising: providing a device to treat urinary incontinence including acuff that is sized for placement around a urethra of a user andconfigured to coapt the urethra in treating diagnosed urinaryincontinence, a pump sized to move liquid out of the cuff to provide thecuff with a collapsed state that allows the urethra to pass urine, and atube connected between the cuff and the pump; fabricating the tube toinclude a first lumen separated from a second lumen by a wall internalto the tube; fabricating at least a portion of an exposed exterior wallof the second lumen to expand to provide the second lumen with aninflatable storage compartment; and providing to a surgeon instructionsfor use on implantation of the device.
 21. A method of treating urinaryincontinence, the method comprising: providing a device to treat urinaryincontinence, the device including a cuff, a pump, andpressure-regulating storage compartment; implanting the cuff around aportion of a urethra of a user; implanting the pump into one of ascrotum of a male user and a labia of a female user; and connecting afirst end of the pressure-regulating storage compartment to the cuff andconnecting a second end of the pressure-regulating storage compartmentto the pump.